- Clinical stage drug development company Evgen Pharma said it had filed an orphan drug designation request with the US Food and Drug Administration for use of its lead drug candidate SFX-01 to treat malignant glioma.

It is expected that, if granted, orphan drug status would be conferred for SFX-01 in the US this year, the company said.

A successful orphan drug 'confers separate intellectual property cover to an investigational drug in the form of data protection which is additional to any patent cover in force,' it added.

'In parallel, an investigational new drug dossier is being prepared for submission to the FDA around the end of the year, to support a Phase II trial in glioma/glioblastoma that is being planned for commencement in H1/2022.'

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